FDA.reportPublic FDA data

Holter Analysis Software

Primary DI
M581NEMK1610
Brand
Holter Analysis Software
Company
Northeast Monitoring, Inc.
Model
Enhanced
Catalog number
NEMK161
Device description
Holter Analysis Software Enhanced
Published
2021-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930564000HOLTER FOR WINDOWSNorth East Monitoring, Inc.1995-04-19DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M581NEMK1610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac arrhythmia monitoring systemAn assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
837441815
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M581NEMK1290DR200DR200 3LNEMK1292021-10-27
M581NEMK1380DR181DR181 5LNEMK1382021-10-27
M581NEMK1390DR181DR181 7LNEMK1392021-10-27
M581NEMK1400DR181DR181 12L2021-10-27
M581NEMK1540DR300DR300 5LNEMK1542021-10-27
M581NEMK1550DR300DR300 7LNEMK1552021-10-27
M581NEMK1560GatewayGatewayNEMK1562021-10-27
M581NEMK1570DR400DR400NEMK1572021-10-27
M581NEMK1600Holter Analysis SoftwareBasicNEMK1602021-10-27
M581NEMK1620Holter Analysis SoftwareEnhanced PlusNEMK1622021-10-27
M581NEMK1630Holter Analysis SoftwareProNEMK1632021-10-27
M581NEMK1950LX EventLX Event ToolNEMK1952021-10-27
M581NEMK940DR200DR200 2LNEMK942021-10-27
M581NEMK950DR200DR200 5LNEMK952021-10-27
M581NEMK960DR200DR200 7LNEMK962021-10-27
M582NEMK1270Holter Analysis Software ApneaHolter Analysis Software ApneaM582NEMK1272021-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
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09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
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17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
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08719689142124QMAPP Fysicon B.V.DQK2026-05-19
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